WEST CHESTER, PA — Centinel Spine®, LLC, a global medical device company addressing cervical and lumbar spinal disease through anterior surgical access, recently announced findings of a new study first presented at the annual meeting of the International Society for the Advancement of Spinal Surgery (ISASS) (May 13-15, 2021, Miami, FL).
Thierry Marnay, MD reported results that strongly support the long-term safety and effectiveness of Centinel Spine’s prodisc® L Total Disc Replacement System for the lumbar spine. Results from this study will be further presented during the Best Paper session at the upcoming North American Spine Society (NASS) 36th Annual Meeting on Thursday, September 30, 2021.
The study expands the evidence of prodisc L and is one of the largest total disc replacement patient groups ever evaluated—demonstrating the robust long-term clinical success of one- and two-level lumbar total disc replacement (TDR) with prodisc L, as assessed at 7-21 years postoperatively. A total of 1,187 patients who underwent lumbar TDR from 1999 to 2013 were followed. Until this study, lumbar TDR published evidence was limited to 5-7 year follow up.
According to the study, patients had maintained reduction in disability and pain scores over time, with low rates of index revision/reoperation or adjacent level surgery when compared to long-term published fusion data. Total TDR revision and adjacent level surgery rates over 7-21 years were 0.67% and 1.85%, respectively (Marnay, Thierry. “7 to 21 year clinical outcomes of 1,187 patients treated with one and two level lumbar total disc arthroplasty”, ISASS 2021 Annual Meeting, May 14, 2021, Miami, FL).
Centinel Spine’s CEO, Steve Murray, stated, “This study reinforces the long-term safety and effectiveness of the prodisc system, a motion preservation technology that supports the advancement of patient care. The prodisc technology was designed on proven design principles and this study demonstrates continued positive results after over 30 years of clinical usage.”
Centinel Spine continues to lead the total disc replacement market and is the only company with FDA-approved cervical and lumbar total disc replacement devices. The prodisc L remains the only total disc replacement system in the U.S. approved for two-level use in the lumbar spine.
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